TECHNICAL INFORMATION

Technical Specification of the European and US Standards for Medical Face Masks

How to interpret this Technical Table?

To ensure the quality and protection of these products, relevant standards exist for their manufacture. As an example, two regularly cited standards are the EU and US standards:
• EU: EN 14683:2019 – Medical Face Masks. Requirements and test methods
• US: ASTM F2100-19 (American Society for Testing and Materials) Standard Specification for Performance of Materials Used in Medical Face Masks.

To demonstrate what these standards mean for mask performance, an EN 14683 Type II/ASTM Level 1 mask will need to meet the following specifications:
Bacteria Filtration Efficiency (BFE): 98% (Size of typical bacteria at 3-5 microns)
Particulate Filtration Efficiency (PFE):95% 0.1 micron particle size (equivalent to an aerosol mist like particle)
Differential Pressure (Delta P): <6.0 mmH2O/cm2 (In terms of Breathability – low value is better; In terms of filtration -high value is better)
Fluid resistance: 80 mmHg (Measure the ability to resist fluids at a specified pressure; Level 1 = 80mmHg, Level 2 = 120mmHG, Level 3 = 160 mmHg)

How to test your facemask if it is safe, in your home setting
1. The flame test: When you put on a mask and try to blow out a flame and it does not blow out, then it passes the test of filtration efficiency.
2. The water test: When you put a water droplet into the mask, it should repel water and not go through, simulating what it’s like when we cough.

Types of face masks
The first step in identifying the face mask to fit your requirements is to know the different types. Face masks are broken down into 2 main categories: Medical masks and Respirators.
Here are some types of masks you might have heard of:
• Type I Face Mask
• Type II Face Mask
• Type IIR Face Mask
• FFP1 Face Mask
• FFP2 Face Mask
• FFP3 Face Mask
• N95 Face Mask

What’s the difference between Type I, Type II and Type IIR Masks?
Medical face masks must comply with the Medical Devices Directive and the European standard EN 14683. Type I face mask has a BFE (bacterial filtration efficiency) of 95%, to be worn by patients, not medical staff. Whereas Type II and Type IIR face masks have a BFE of 98% they are to be worn by medical staff.
Type I, Type II and Type IIR face masks are medical masks tested in the direction of exhalation (inside to outside) and accounted to the efficiency of bacterial filtration, designed to be effective in reducing the emission of infective agents from the nose and throat during health care procedures. Although medical masks are not respiratory masks, they can provide protection, forming a physical barrier to nasal and oral mucous membranes, preventing the transmission of microorganisms through droplets or splashes of infected material, from an asymptomatic carrier or a patient with clinical symptoms.

What is a Type II Face Mask?
Type II face mask is medical face masks made up of a protective 3 ply construction that prevents large particles from reaching the patient or working surface. Type II and Type IIR – these masks are principally intended for use by healthcare professionals in an operating room or other medical settings with similar requirements. Type II is further divided according to whether the mask is splash resistant. The R signifies splash resistance, used particularly as a surgical device in an operating room setting. These products are certified under the European Medical Devices Regulation as a Class I device, so they must be CE marked.
Characteristics of Type II face masks include:
• Pleat style with ear loops or ties
• Protective three-layer construction
• Available in a variety of colours and styles.

What is a Type IIR Face Mask?
Type IIR face mask is medical face masks made up of a 3 or 4 Ply construction that prevents large particles from reaching the patient or working surfaces. Type IIR Face masks; R signifies splash resistant layer to protect against blood and other bodily fluids in an operating room setting. Type IIR face masks are tested in the direction of exhalation (inside to outside) and accounted the efficiency of bacterial filtration of >99%.
Characteristics of Type IIR face masks include:
• Pleat style with ear loops or ties
• Protective four-layer construction
• Available in a variety of colours and styles
• Splash resistant layer against bodily fluids.

The following information shall appear on the product or packaging:
• Number of the European Standard followed by the year of publication of the standard. E.g. EN14683:2019 (latest publication)
• Type of Mask: Type I, Type II, Type IIR
• CE Marking, Compliance Certificate from authentic sources, or QR scan code.

Respiratory Protection Masks

What’s the difference between FFP1, FFP2, FFP3, N95, N99 and N100 Face Masks?
FFP1, FFP2 & FFP3 Face Masks are European classes of respirators, tested on the direction of inspiration (outside to inside) and considers leakage to the face and filtration efficiency.
FFP1, this is the lowest level of performance a protective mask can offer. This mask has an efficiency of at least 80% against airborne particles. The side leakage (around the face) must not exceed 22%. This mask is used when the norovirus is present
FFP2 face masks are the equivalent of N95 face masks, which meet the guidelines from The World Health Organisation for protection against Covid-19. FFP2 masks have a minimum of 94% filtration percentage and a maximum of 8% leakage to the inside. These masks are not shaped to your face but are simply held in place by the elastic ear loop and have a typical lifespan of 3-8 hours depending on environmental factors.
FFP3 face masks are the most effective at filtration, with a minimum filtration of 99% and a maximum leakage of 2% to the inside. These masks are better shaped to your face for a snugger fit and typically have a valve to help breathe as the filtration material is much thicker. The valve also reduces the build-up of moisture, lengthening the lifespan of the mask. However, there is contention to the valve fit at this moment, due to contamination reasons FFP3 masks are typically used for handling asbestos.

FFP2, FFP3, N95, N99, N100 and other respirator masks are effective at protecting the wearer from viral or airborne transmission.

The following indications are present on the product:
• The standard with which the product complies + the year of publication of the standard, e.g. EN 149:2001+A1:2009 (latest publication)
• The class to which the product conforms (FFP1, FFP2, FFP3, N95, N99, N100)
• CE Marking and notified body number

If these statements are not present, it is not certain that the masks are in conformity with the standard. It is then possible that they do not offer (the needed) protection.

What are the US and European Standards for face masks?
Medical masks and Respirators undergo different standards and regulations, dependent on the geographical area to which they are manufactured.

Medical masks in Europe must comply with the European standard EN 14683, which have 3 levels of bacterial filtration efficiency (BFE1, BFE2, Type R). In the US medical masks must comply with ASTM standards, which have three levels of protection (from low risk of exposure to fluids to high risk of exposure to fluids).

Respirators in Europe must meet European standard EN 149: 2001, which includes three classes of disposable particulate respirators (FFP1, FFP2 and FFP3). In the US respirators must comply with NIOSH (National Institute for Occupational Safety and Health) standards.

Within this standard, there are several classes of respirators depending on the degree of oil resistance:
• Class N: no oil resistance. A distinction is made between N95, N99 and N100. The number after the letter indicates the percentage of filtration of suspended particles.
• Class R: mask resistant to oil for up to eight hours. Here again, a distinction is made between R95, R99 and R100.
Class P: a completely oil-resistant mask. There are also P95, P99 and P100.

References & Articles: Technical Information
1. BSI (The British Standards Institution), By Royal Charter
2. Centexbel Belgium, testing Coronavirus Disease Covid-19, Guide for more information. What tests are medical face masks subjected to and how can I be sure that the mask I purchased meets the requirements? More information at https://www.centexbel.be/en/testing/evaluation-medical-face-masks
3. How do we evaluate the safety of your (home-made) textile mask?
https://www.centexbel.be/en/testing/coronavirus-community-mask-testing
4. The Journal for a Career in Dental Nursing, UK, Author: Julie Bissett

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